JPH04317644A - Silicon processed surgical needle and manufacture thereof - Google Patents

Abstract

PURPOSE: To provide a silicon treated surgical needle which shows an average tissue invasion force smaller than normal. CONSTITUTION: After the same tissue is continuously passed, for a silicon treated surgical needle which shows an average tissue invasion force smaller than an average tissue invasion force of a normal silicon treated surgical needle at least by 10%, a silicon coating of the needle is silicon-treated with a silicon treating material which contains an aminoalkylsiloxane, and at least one kind of other siloxane which can be copolymerized with the aminoalkylsiloxane.

Description

[Detailed description of the invention]

0001

FIELD OF THE INVENTION This invention relates to a surgical needle having a silicone resin coating that provides reduced tissue penetration force, and to a method of manufacturing the same.

0002

BACKGROUND OF THE INVENTION Siliconization of the metallic cut ends of articles such as razor blades, hypodermic needles, scissors, scalpels, and curettes.
on) have been known for some time. US Patent No. 3
, 574,673 describes the silicone coating of cut ends using a silicone treatment solution containing a mixture of copolymerizable silicones made from aminoalkylsiloxanes, specifically (polyaminoalkyl)alkoxysilanes, and dimethylpolysiloxanes. is disclosed.

[0003] Dow Corning Corporation (D
ow Corning Corporation Publication 51-599A (July 1986) describes an ambient temperature and humidity curable mixture of an aminoalkylsiloxane and a cyclosiloxane dissolved in a mixture of Stoddard solvent and isopropyl alcohol. Dow Corning® MDX4- for siliconizing cut ends such as liquids containing
4159 liquid is described. It is recommended that the liquid be applied by dipping, smearing, spraying, etc. in the form of a dilute organic solution prepared in a solvent such as hexane, trichlorotrifluoroethane, 1,1,1-trichloroethane or mineral spirits. has been done.

US Pat. No. 4,720,521 discloses a film-forming method for application to the above cut edge articles containing a mixture of three reactive siloxanes together with a non-reactive lubricating siloxane polymer. A siloxane composition is described.

[0005]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a siliconized surgical needle in which the needle exhibits an average tissue penetration force that is less than the average tissue penetration force of conventional siliconized surgical needles, and An object of the present invention is to provide a method for siliconizing a needle. A particular object of the present invention is to provide a surgical needle having an adhesive silicone coating derived from a siliconized material containing an aminoalkylsiloxane and at least one other siloxane such as a cyclosiloxane copolymerizable therewith. be.

Another specific object of the present invention is to provide a method of silicone treatment performed on a surgical needle having an axial lumen or recess for receiving the tip of a suture. The siliconization method eliminates the step of occluding the lumen with water in preparation for applying the siliconization material to the needle.

[0007]

SUMMARY OF THE INVENTION In order to achieve these and other objects of the present invention, silicone which exhibits an average tissue penetration force that is less than the average tissue penetration force of conventional siliconized surgical needles is provided. A treated surgical needle is provided. The siliconized needles of the present invention are made by applying a siliconized material containing an aminoalkyl siloxane and at least one other silicone copolymerizable therewith to the surface of the needle, and then curing the siliconized material onto the needle. It can be obtained by forming an adhesive silicone coating.

[0008] The "ordinary silicone-treated surgical needle" used in the present invention refers to commercially available silicone-treated surgical needles,
For example, Ethicon, Inc., Somerville, New Jersey.
represents a siliconized surgical needle sold by ).

The amount of force required to penetrate the tissue during suturing (hereinafter referred to as needle penetration force) initially differs between the siliconized surgical needle of the present invention and the conventional siliconized surgical needle. may be approximately the same for both surgical needles, but both needles tend to experience an increase in penetration force with each successive passage through the tissue, and at the end of a given number of such passages. , the needles of the present invention exhibit significantly lower penetration forces than conventional needles. In other words, the siliconized needles of the present invention retain their initial tissue penetration properties to a greater extent than conventional siliconized needles. This reduced tissue penetration force is advantageous as it reduces the effort required during suturing operations, which is a particular advantage when extensive wound closure is involved.

Surgical needles that can be siliconized in accordance with the present invention can be made from a variety of metals, such as Series 400 and Series 300 stainless steel. Other metals suitable for fabrication of surgical needles include the quaternary alloys disclosed in U.S. Pat. Nos. 3,767,385 and 3,816,920, the contents of which are incorporated herein by reference. Included in the statement. Particularly preferred quaternary alloys have the composition ranges shown in Table 1 below.

[0011]

[Table 1] Composition (wt%) of quaternary alloy for surgical needles
Wide range Preferred range Most preferred range Nickel 10~
50 24-45 30
~40 cobalt
10~50 25~45
30~40 nickel + cobalt
50-85 60-80
65-75 chrome
10-30 12-24
15-22 Molybdenum, tungsten and/or niobium (columbium) 5-20
8-16 10-13 The special quaternary alloy in Table 1 (designated MP35N) that may be used in the siliconized needles of the present invention is manufactured by Maryland Specialty Wire, Cockeysville, Maryland.・Incorporated (Maryland)
Specialty Wire, Inc. ) available in wire form (with nominal gravimetric analysis) Nickel 3
5%, cobalt 35%, chromium 20% and molybdenum 1
Contains 0%.

[0012] The siliconized material used in the present invention and the maneuver used to apply it have a comparable tissue penetration force to that of a conventional surgical needle after an equal number of passes through the same or substantially the same tissue. This is similar to providing a siliconized surgical needle that exhibits a significantly reduced penetration force. Advantageously, the average tissue penetration force of a siliconized needle of the present invention is equal to the average tissue penetration force of a conventional siliconized needle after 5 to 20 passes through the same or similar tissue. about 10% smaller, preferably about 20% smaller, more preferably about 30% smaller.

Generally, the application of a curable siliconized material containing an aminoalkylsiloxane and at least one other copolymerizable siloxane, such as an alkylpolysiloxane or cyclosiloxane, to a surgical needle, followed by curing, is accomplished by the present invention. Provide a siliconized surgical needle that meets the requirements.

One method suitable for carrying out the silicon processing of the present invention is to use the silicon processing materials and operations described in US Pat. No. 3,574,673, which patent The contents are incorporated herein by reference. The siliconized material comprises (a) about 5-20% by weight of an aminoalkylsiloxane of Formula I; and (b) Formula I:
Containing about 80-95% by weight of a methyl-substituted siloxane of I:

[0015]

[Chemical formula 1]

(wherein R is a lower alkyl group containing up to about 6 carbon atoms; Y is an -OH group and an -OR' group (
where R' is an alkyl group of up to 3 carbon atoms)
selected from the group consisting of; Q is hydrogen, -CH3 and -CH
selected from the group consisting of 2CH2NH2; a is 0 or 1
and b has a value of 0 or 1 and the sum of a+b has a value of 0, 1 or 2):

[0017]

[Case 2]

##STR2## where R'' is selected from the group consisting of --OH and --CH3 groups, and c has a value of 1 or 2.

In addition to or in place of the second copolymerizable siloxane, for example, “Encyclope
dia of Polymer Science an
d Engineering”, edited by Mark et al., 2nd edition, John Wiley & Son (1989), 1
One or more cyclosiloxanes can be used, such as those described in Volume 5, pages 207 et seq., the contents of which are incorporated herein by reference. However, the condition is that the total amount of the second type or more copolymerizable siloxane is, of course, within the above range.

A particularly preferred silicon processing material for use in the present invention is Dow Corning® MDX4-4159 from Dow Corning Corporation.
("MDX Fluid"), which is a 50% active solution of dimethylcyclosiloxane and dimethoxysilyldimethylaminoethylaminopropyl silicone polymer in a mixture of Stoddard solvent (Mineral Spirits) and isopropyl alcohol. MDX liquid is
For example, hexane, trichlorotrifluoroethane, 1
In the form of a dilute organic solution prepared in a solvent such as , 1,1-trichloroethane or mineral spirits, it can be applied to the surface of a cleaned surgical needle by dipping, smearing, spraying, etc. Generally, it is preferred to dilute the MDX fluid (or other silicon processing material) in a hydrocarbon solvent having 5 to 10 carbon atoms, such as pentane, hexane (preferred), heptane, octane, and the like. The MDX fluid cures at room temperature to provide an adhesive silicone coating.

After evaporation of the diluent or solvent carrier,
The siliconized material is cured to the desired degree. The material may be cured by heating at 120° C. for a short period of time, such as 30 minutes, or by exposure to ambient temperature and humidity conditions for an extended period of time.

[0022] As mentioned above, when axially bored surgical needles are concerned, it is preferred to siliconize the needle using a procedure that does not require a preliminary step to temporarily occlude the lumen. Typically, when such needles are siliconized by immersion or full immersion in the siliconized material, it is necessary to occlude the lumen with a liquid that is immiscible with the siliconized material, e.g., water. It turned out to be. Thus, such materials can enter the lumen (
Thus, it prevents the sutures from forming (which may interfere with proper attachment of the sutures). It has been found that the lumen occlusion step can be completely omitted by applying the siliconized material to the needle by spraying. Therefore, spraying at least
For needles with an axial lumen, or recess, is the preferred method of applying the siliconized material.

[0023] Spraying is also commonly used in co-pending US Patent Application No. 07/413, filed September 27, 1989.
Preferred for applying a silicone treatment solution to a needle with a reduced shank end that is intended to be attached to the tip of a suture using a retractable tubular connector such as that disclosed in US Pat. It's a method. The contents of that patent are incorporated herein by reference. For such needles, it is preferred to first insert the needle shank end into a support block, for example of rigid foam, and then spray the exposed surfaces of the needle with a siliconizing solution. Since the shank end of the needle is embedded in the support block, it remains silicone-free during the spraying operation. Of course, the use of a support block may also be used in the case of the axial dimple type needles described above to prevent siliconized material from entering the recess. Preferably, the coated needle is exposed to curing conditions while still in its support block. If this involves heat, it is of course necessary to select a support block material that can withstand the high temperatures chosen for curing.

The following examples are illustrative of the siliconized surgical needles of the present invention and methods of making the same.

[0025]

【Example】

Example 1 This example uses a 1/2 circular curved taper point with a length of 37 mm.
The present invention describes the sheathing of a volume surgical needle (needle A) made from 0.039 inch diameter surgical grade stainless steel wire shaped as a typical surgical needle with aper point). Each needle had an axial recess in its blunt end for receiving the tip of the suture.

[0026] The needle was placed in a basket and soaked in an ultrasonic cleaning unit for 5 minutes. The basket was raised to the steam section of the unit and held there for an additional 5 minutes. The needles were then dried and transferred after 20 minutes to a second basket, which was immersed for 30 seconds in a siliconizing medium prepared from 1 part by volume of MDX liquid and 9 parts by volume of hexane as solvent. After draining off the excess siliconizing medium, the needles were spread out on a tray and heated at 120° C. for 16 hours to effect curing of the silicone coating.

EXAMPLE 2 This example demonstrates the penetration characteristics of needle A of Example 1 using a commercially available siliconized surgical needle of the same diameter and shape, specifically the CT-1 surgical needle from Ethicon Inc.
Compare with needle B). Set needle A to Porva
ir) (Inmont Corporation
Corporation)), or approximately 0.107c
m (0.042 inch) thick microporous polyurethane membrane (this was used to simulate muscle tissue)
The needle was tested by passing 78 samples through it. The amount of force (in g) to obtain penetration of the pobear by the needle was measured for each of the 10 consecutive penetrations for each of the 78 needle samples. The measurement of penetration force is disclosed in co-pending U.S. Patent Application No. 07/541 filed June 20, 1990.
, 055 using the test procedure and equipment described in the specification. The contents of that patent are incorporated herein by reference. Perform the test using test fixtures and Instron®
Universal Testing Machine (Instron)
Universal Testing Machine
). Grasp the surgical needle and attach it to the clamp.
This clamp fixed the needle in a position oriented with its radial profile perpendicular to the PoBear surface and with its axis of rotation in the same plane as the PoBear surface. The needle was rotated in a Povera attached to the top of an Instron load cell. The maximum amount of vertical force as the needle was pushed into the Pobear was recorded.

Except that 73 individual needle samples were evaluated.
Needle B was tested in the same manner as Needle A. The average penetration force for all needles measured on each successive pass through the PoBear and the average penetration force of the needles after a total of 10 passes through the PoBear are shown in Table 2 below.

[0029]

[Table 2] Needle penetration force

10 successes
Average penetration force (g)
Passage during Pobear 1 2 3 4 5 6 7
8 9 10 Average Needle A
196 278 326
373 396 411 429 450 477 4
84 381 Needle B
207 284 393 490 603 6
57 681 732 747 791 55
7 These data show that the average penetration force for both sets of needles A and B was approximately the same during the first pass of the needles in Paw Bear, but with each successive pass, the greater force increased. Needle A requires less force to achieve penetration than needle B, with a total of 10 in the Paw Bear for needle A. The average penetration force for the passes was 30% less than the penetration force required for needle B.

EXAMPLE 3 This example demonstrates how one needle A of Example 1 uses a spray operation.
The silicon processing of 0 samples will be explained. Before spraying, the needles were ultrasonically cleaned as in Example 1 and transferred to a tray where they were placed on their side. The silicone treatment solution of Example 1 was sprayed onto the needle using a spray bottle, and the liquid was
It was applied evenly over the surface of the needle over a period of 0 minutes. Thereafter, the needle was baked to harden the silicone treatment solution. Unlike the siliconization method used in Example 1, in which the siliconization solution tended to migrate into the axial recess formed in the blunt end of the needle, the spray operation of this example The tendency for liquid to enter the recesses was greatly reduced. Thus, spraying siliconized material into the needle as it tends to minimize or avoid the presence of silicone in the needle cavity (that material can interfere with proper suture attachment). It is clear that this is a more advantageous technique for coating.

Using the needle penetration test procedure described in Example 2, the following penetration data were obtained.

[0032]

[Table 3]

Claims (25)

[Claims] 1. A siliconized surgical needle characterized in that it exhibits an average tissue penetration force that is lower than the average tissue penetration force of a typical siliconized surgical needle. 2. Exhibits an average tissue penetration force that is at least 10% less than the average tissue penetration force of a conventional siliconized surgical needle after an equal number of consecutive passes through the same or substantially the same tissue. The siliconized surgical needle according to claim 1. 3. Exhibits an average tissue penetration force that is at least 20% less than the average tissue penetration force of a conventional siliconized surgical needle after an equal number of consecutive passes through the same or substantially the same tissue. The siliconized surgical needle according to claim 1. 4. Exhibits an average tissue penetration force that is at least 30% less than the average tissue penetration force of a conventional siliconized surgical needle after an equal number of consecutive passes through the same or substantially the same tissue. The siliconized surgical needle according to claim 1. 5. The siliconized surgical needle of claim 1, which exhibits an average tissue penetration force of less than about 500 g after ten consecutive passes. Claim 6: The uncovered needle is approximately 0.099c.
6. The siliconized surgical needle of claim 5 having a diameter of 0.039 inches. 7. The siliconized surgical needle of claim 1, wherein the silicone coating of the needle is obtained from a siliconized material comprising an aminoalkylsiloxane and at least one other siloxane copolymerizable therewith. 8. The siliconized surgical needle of claim 1, wherein the silicone coating of the needle is obtained from aminoalkylsiloxanes and alkylpolysiloxanes. 9. The silicone coating of the needle is obtained from aminoalkylsiloxane and cyclosiloxane.
The silicone-treated surgical needle described in . 10. The silicone coating of the needle is obtained from a siliconized material comprising an aminoalkylsiloxane, at least one other siloxane copolymerizable therewith, and at least one hydrocarbon solvent of 5 to 10 carbon atoms. 1. The silicone-treated surgical needle according to 1. 11. The siliconized needle according to claim 1, wherein the silicone coating of the needle is obtained from a siliconized material comprising at least one hydrocarbon solvent selected from the group consisting of aminoalkylsiloxanes, cyclosiloxanes, and hexane and heptane. Surgical needle. 12. The siliconized surgical needle of claim 1, wherein the needle is fabricated from an alloy containing nickel, cobalt, chromium, and at least one metal selected from the group consisting of molybdenum, tungsten, and niobium. 13. The needle comprises about 10% to about 50% by weight nickel, about 10% to about 50% by weight cobalt (the combined weight of nickel and cobalt is about 50% to about 85% by weight),
2. The siliconized silicon-treated silicone of claim 1 fabricated from an alloy comprising about 10 to about 30 weight percent chromium and about 5 to about 20 weight percent at least one metal selected from the group consisting of molybdenum, tungsten, and niobium. Surgical needle. 14. A method for producing a siliconized surgical needle, characterized in that a siliconized material containing an aminoalkylsiloxane is applied to the surface of the needle, and the siloxane is then cured to obtain a silicone coating. 15. The method of claim 14, wherein the silicone coating of the needle is obtained from a siliconized material comprising an aminoalkylsiloxane and at least one other siloxane. 16. The method of claim 14, wherein the silicone coating of the needle is obtained from a siliconized material comprising an aminoalkylsiloxane and a cyclosiloxane. 17. The method of claim 14, wherein the silicone coating of the needle is obtained from a siliconized material comprising an aminoalkylsiloxane and at least one hydrocarbon solvent of 5 to 10 carbon atoms. 18. The silicone coating of the needle is obtained from a siliconized material containing at least one hydrocarbon solvent selected from the group consisting of aminoalkylsiloxanes, cyclosiloxanes, and hexane and heptane.
The method described in. 19. The method of claim 14, wherein the needle is fabricated from an alloy containing nickel, cobalt, chromium, and at least one metal selected from the group consisting of molybdenum, tungsten, and niobium. 20. The needle comprises about 10 to about 50% by weight nickel, about 10 to about 50% by weight cobalt (the combined weight of nickel and cobalt is about 50 to about 85% by weight),
15. The silicon-treated silicon-treated silicone according to claim 14, which is fabricated from an alloy comprising about 10 to about 30 weight percent chromium and about 5 to about 20 weight percent at least one metal selected from the group consisting of molybdenum, tungsten, and niobium. Surgical needle. 21. A method of manufacturing a siliconized surgical needle from a surgical needle having an axial recess at its blunt end for receiving a suture in the upper part, the recess being hardened while unoccluded. spraying the siliconized material onto the needle (a significant amount of the siliconized material does not enter its lumen) and then curing the siliconized material on the needle to obtain a silicone coating thereon. The above manufacturing method. 22. The method of claim 21, wherein the silicon treatment material comprises an aminoalkyl siloxane and at least one other siloxane. 23. The method of claim 21, wherein the shank end of the needle is embedded in the support material during spraying. 24. Embedding the shank in a support material, spraying a curable siliconized material onto the exposed surface of the needle, and then curing the siliconized material on the needle to obtain a silicone coating thereon. A method of manufacturing a siliconized surgical needle from a surgical needle having a reduced diameter shank. 25. The method of claim 24, wherein the siliconized material comprises an aminoalkylsiloxane and at least one other siloxane.